Spinal implant system and method

ABSTRACT

A surgical instrument comprises a first member including a drive engageable with a first mating surface of a bone fastener. A second member is rotatable relative to the first member and includes an engagement element connectable with a second mating surface of the bone fastener. Systems, spinal implants and methods are disclosed.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to aspinal implant system and a method for treating a spine.

BACKGROUND

Spinal pathologies and disorders such as scoliosis and other curvatureabnormalities, kyphosis, degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, tumor and fracture may resultfrom factors including trauma, disease and degenerative conditionscaused by injury and aging. Spinal disorders typically result insymptoms including deformity, pain, nerve damage, and partial orcomplete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes correction, fusion, fixation, discectomy, laminectomy andimplantable prosthetics. As part of these surgical treatments, spinalconstructs such as vertebral rods are often used to provide stability toa treated region. Rods redirect stresses away from a damaged ordefective region while healing takes place to restore proper alignmentand generally support vertebral members. During surgical treatment, oneor more rods and bone fasteners can be delivered to a surgical site. Therods may be attached via the fasteners to the exterior of two or morevertebral members. Surgical treatment may employ surgical instrumentsand implants that are manipulated for engagement with vertebrae toposition and align one or more vertebrae. This disclosure describes animprovement over these prior technologies.

SUMMARY

In one embodiment, a surgical instrument is provided. The surgicalinstrument comprises a first member including a drive engageable with afirst mating surface of a bone fastener. A second member is rotatablerelative to the first member and includes an engagement elementconnectable with a second mating surface of the bone fastener. In someembodiments, systems, spinal implants and methods are disclosed.

In one embodiment, the surgical instrument includes an outer tubularsleeve extending between a proximal end and a distal end. The distal endincludes a drive engageable with a drive socket of a bone fastenershaft. An inner shaft is rotatable relative to the sleeve and includes ascrew connectable with an inner threaded surface of a bone fastenerreceiver.

In one embodiment, a spinal implant system is provided. The spinalimplant system comprises a surgical instrument including an outertubular sleeve extending between a proximal end and a distal end. Thedistal end includes a drive engageable with a bone fastener shaft. Aninner shaft of the surgical instrument is rotatable relative to thesleeve and includes a screw connectable with a threaded surface of abone fastener receiver. An implant support includes extender tabsconfigured for engagement with the bone fastener receiver. A guidemember includes an inner surface that defines a cavity configured fordisposal of the sleeve and an image guide being oriented relative to asensor to communicate a signal representative of a position of the guidemember.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 2 is a cross section view of the components shown in FIG. 1;

FIG. 3 is a perspective view of components of the system shown in FIG.1;

FIG. 4 is a break away view of components of the system shown in FIG. 1;

FIG. 5 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 6 is a perspective view of components of the system shown in FIG. 5with parts separated;

FIG. 7 is a break away view of components of the system shown in FIG. 6;

FIG. 8 is a break away view of components of the system shown in FIG. 5;

FIG. 9 is a perspective view of components of the system shown in FIG. 5with parts separated;

FIG. 9A is an enlarged view of detail A shown in FIG. 9;

FIG. 10 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 11 is a perspective view of the components of the system shown inFIG. 10;

FIG. 12 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 13 is a perspective view of components one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 14 is a break away view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure; and

FIG. 15 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure.

DETAILED DESCRIPTION

The exemplary embodiments of the surgical system and related methods ofuse disclosed are discussed in terms of medical devices for thetreatment of musculoskeletal disorders and more particularly, in termsof a spinal implant system and a method for treating a spine. In someembodiments, the systems and methods of the present disclosure comprisemedical devices including surgical instruments and implants that areemployed with a surgical treatment, as described herein, for example,with a cervical, thoracic, lumbar and/or sacral region of a spine.

In some embodiments, the present surgical system comprises a surgicalinstrument that comprises a screw driver that can be employed with bonefasteners and one or more implant supports, such as, for example, anextender, for treating a spine. In some embodiments, the presentsurgical system includes a surgical instrument that can easily connectand disconnect from a bone fastener. In some embodiments, an extendercan be connected in alignment with the surgical instrument to facilitatemanipulation. In some embodiments, the present surgical system includesa surgical instrument that can be employed with an end effector of arobotic arm to facilitate implant with the robotic arm. In someembodiments, the surgical instrument is guided through the end effectorfor a guide-wireless screw insertion. In some embodiments, the surgicalinstrument comprises a robot screw driver employed with robotic and/ornavigation guidance, which may include an image guide.

In some embodiments, the present surgical system includes a screw driverhaving an outer shaft and a drive tip that engages a bone fastener. Insome embodiments, the outer shaft and the drive tip are of one piececonstruction. In some embodiments, the one piece construction allowstolerances to be controlled tightly for improved accuracy of trajectoryduring implant insertion. In some embodiments, the drive tip includes aTorx configuration. In some embodiments, the present surgical systemincludes a screw driver having an internal retention mechanism. In someembodiments, the retention mechanism is fixed with a receiver of a bonefastener to resist and/or prevent disengagement of the retentionmechanism from the receiver, for example, due to connection or frictionwith the end effector or tissue.

In some embodiments, the present surgical system includes a screw driverfor use with robotic surgery. In some embodiments, the screw driver canbe employed with fixed-axis screws (FAS), uni-axial screws (UAS),sagittal adjusting screws (SAS), transverse sagittal adjusting screws(TSAS) and multi-axial screws (MAS) screws, and allows the screws to bedriven through a robotic end effector. In some embodiments, the screwdriver includes a one piece outer sleeve having a tip. In someembodiments, the screw driver includes an internal retaining device thatprevents accidental disengagement and/or unthreading.

In some embodiments, the present surgical system includes a screw driverincluding an outer shaft or sleeve having an outside diameter that isslightly larger than a screw spin diameter of a bone screw. Thisconfiguration allows the bone screw and the screw driver to pass throughthe end effector. In some embodiments, the screw driver includes a thumbwheel that is connected to a retention screw that threads into the bonescrew. In some embodiments, the present surgical system includes tabextenders connected to the screw driver and prevented from extendingoutside the outside diameter of the screw driver by engaging undercutsof the screw driver. This configuration prevents an interference orhang-up if the bone screw needs to be removed through the end effector.

In some embodiments, the present surgical system includes a screw driverthat is employed with a method of assembling components of the presentsystem, which includes the step of connecting a bone screw to the screwdriver. In some embodiments, the method includes the step of inserting adrive tip of the screw driver into a drive socket of a receiver of thebone screw while aligning tab extenders in mating grooves of the screwdriver. In some embodiments, the method includes the step of rotating athumb wheel actuator of the screw driver to tighten and pull the bonescrew tight against the screw driver. In some embodiments, the methodincludes the step of inserting the retention screw and thumb wheellaterally with an outer shaft/sleeve of the screw driver. In someembodiments, the method includes sliding an inner shaft of the screwdriver from a rear orientation. In some embodiments, the retentionscrew, thumb wheel and inner shaft include mating surfaces having adouble D shape to transmit torque. In some embodiments, the methodincludes internal parts that are retained by inserting a quick connectshaft from a rear orientation and welding the quick connect shaft to theouter shaft.

In some embodiments, the present surgical system includes a screw driverthat includes a quick connect shaft, an inner shaft, a thumb wheel, anouter driver shaft and a retention screw. The inner shaft, thumb wheeland retention screw include double D or hex shape mating surfaces. Insome embodiments, the screw driver includes cleaning slots for flushingand/or cleaning. In some embodiments, the thumb wheel, retention screwand inner shaft freely float within the assembly. In some embodiments,the retention screw can freely translate axially relative to the innershaft or up and down along the inner shaft. In some embodiments, theretention screw and the thumb wheel are keyed to a double-Dconfiguration of the inner shaft. In some embodiments, the retentionscrew is axially translatable relative to the inner shaft between afirst position, for example, a non-locking position prior to tightening,and a second position, for example, a locking position after tightening.In some embodiments, this configuration allows the drive tip to engagethe bone screw prior to rotating the thumb wheel for tightening thescrew driver to the bone screw.

In some embodiments, the surgical system includes an implant support,such as, for example, a collar and extender tabs. In some embodiments,the surgical system is employed with a method for treating spinal traumaand/or deformity disorders. In some embodiments, the surgical system isemployed with a method for treating spinal trauma and/or deformitydisorders with a minimally invasive surgical technique.

In some embodiments, the surgical system includes extender tabs. In someembodiments, the extender tabs are configured for aligning an implant,such as, for example, a bone fastener, with various instruments andproviding an access path for set screws and rods. In some embodiments,the extender tabs are connectable with a SAS. In some embodiments, thesurgical system facilitates sagittal correction and/or manipulation whena spinal implant, such as, for example, a spinal rod is disposed with areceiver. In some embodiments, the extender tabs are connectable with aTSAS. In some embodiments, the surgical system includes a receiver thatis configured to accommodate transverse and sagittal anatomicaldifferences.

In some embodiments, the surgical system of the present disclosure maybe employed to treat spinal disorders such as, for example, degenerativedisc disease, disc herniation, osteoporosis, spondylolisthesis,stenosis, scoliosis and other curvature abnormalities, kyphosis, tumorand fractures. In some embodiments, the surgical system of the presentdisclosure may be employed with other osteal and bone relatedapplications, including those associated with diagnostics andtherapeutics. In some embodiments, the disclosed surgical system may bealternatively employed in a surgical treatment with a patient in a proneor supine position, and/or employ various surgical approaches to thespine, including anterior, posterior, posterior mid-line, directlateral, postero-lateral, and/or antero-lateral approaches, and in otherbody regions. The surgical system of the present disclosure may also bealternatively employed with procedures for treating the lumbar,cervical, thoracic, sacral and pelvic regions of a spinal column. Thesurgical system of the present disclosure may also be used on animals,bone models and other non-living substrates, such as, for example, intraining, testing and demonstration.

The surgical system of the present disclosure may be understood morereadily by reference to the following detailed description of theembodiments taken in connection with the accompanying drawing figures,which form a part of this disclosure. It is to be understood that thisapplication is not limited to the specific devices, methods, conditionsor parameters described and/or shown herein, and that the terminologyused herein is for the purpose of describing particular embodiments byway of example only and is not intended to be limiting. In someembodiments, as used in the specification and including the appendedclaims, the singular forms “a,” “an,” and “the” include the plural, andreference to a particular numerical value includes at least thatparticular value, unless the context clearly dictates otherwise. Rangesmay be expressed herein as from “about” or “approximately” oneparticular value and/or to “about” or “approximately” another particularvalue. When such a range is expressed, another embodiment includes fromthe one particular value and/or to the other particular value.Similarly, when values are expressed as approximations, by use of theantecedent “about,” it will be understood that the particular valueforms another embodiment. It is also understood that all spatialreferences, such as, for example, horizontal, vertical, top, upper,lower, bottom, left and right, are for illustrative purposes only andcan be varied within the scope of the disclosure. For example, thereferences “upper” and “lower” are relative and used only in the contextto the other, and are not necessarily “superior” and “inferior”.

As used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, microdiscectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. In some embodiments, as used inthe specification and including the appended claims, the term “tissue”includes soft tissue, ligaments, tendons, cartilage and/or bone unlessspecifically referred to otherwise.

The following discussion includes a description of a surgical systemincluding a surgical instrument, related components and methods ofemploying the surgical system in accordance with the principles of thepresent disclosure. Alternate embodiments are also disclosed. Referenceis made in detail to the exemplary embodiments of the presentdisclosure, which are illustrated in the accompanying figures. Turningto FIGS. 1-13, there are illustrated components of a surgical system,such as, for example, a spinal implant system 10.

The components of spinal implant system 10 can be fabricated frombiologically acceptable materials suitable for medical applications,including metals, synthetic polymers, ceramics and bone material and/ortheir composites. For example, the components of spinal implant system10, individually or collectively, can be fabricated from materials suchas stainless steel alloys, aluminum, commercially pure titanium,titanium alloys, Grade 5 titanium, super-elastic titanium alloys,cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, superelasto-plastic metals, such as GUM METAL®), ceramics and compositesthereof such as calcium phosphate (e.g., SKELITE™), thermoplastics suchas polyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyimide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft, allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate, tri-calcium phosphate (TCP),hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymerssuch as polyaetide, polyglycolide, polytyrosine carbonate,polycaroplaetohe and their combinations.

Various components of spinal implant system 10 may have materialcomposites, including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of spinal implant system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of spinal implant system 10 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Spinal implant system 10 is employed, for example, with a fully opensurgical procedure, a minimally invasive procedure includingpercutaneous techniques, and mini-open surgical techniques to deliverand introduce instrumentation and/or a spinal implant, such as, forexample, a bone fastener, at a surgical site of a patient, whichincludes, for example, a spine. In some embodiments, the spinal implantcan include one or more components of one or more spinal constructs,such as, for example, interbody devices, interbody cages, bonefasteners, spinal rods, tethers, connectors, plates and/or bone graft,and can be employed with various surgical procedures including surgicaltreatment of a cervical, thoracic, lumbar and/or sacral region of aspine.

Spinal implant system 10 includes a surgical instrument, such as, forexample, a driver 12. Driver 12 can be employed with an end effector 200(FIG. 10) of a robotic arm R (FIG. 13) to facilitate implant withrobotic arm R. Driver 12 is guided through end effector 200 forguide-wireless insertion of a spinal implant, such as, for example, abone fastener 100, as described herein.

Driver 12 includes a member, such as, for example, an outer tubularsleeve 14. Outer sleeve 14 extends between a proximal end 18 and adistal end 20. Outer sleeve 14 defines a longitudinal axis a. In someembodiments, outer sleeve 14 may have various configurations including,for example, round, oval, polygonal, irregular, consistent, variable,uniform and non-uniform. Outer sleeve 14 includes a diameter D1. In someembodiments, diameter D1 is slightly larger than a screw spin diameterD2 of bone fastener 100. This configuration allows bone fastener 100 anddriver 12 to pass through end effector 200 of the robotic arm, asdescribed herein.

Outer sleeve 14 includes a surface 50 that defines a channel 52. Channel52 is configured for disposal of a member, such as, for example, aninner shaft 56 and an engagement element, such as, for example, a screw64, as described herein. Outer sleeve 14 includes a collar body 16having a surface 80. Surface 80 defines a cavity 82. Body 16 includesbifurcated arms 92 disposed about cavity 82 to facilitate disposal andaccess to an actuator, such as, for example, a thumb wheel 84 therein.Body 16 includes opening 94 disposed at end 18. Opening 94 is incommunication with cavity 82 and in alignment with channel 52 tofacilitate insertion of inner shaft 56 into end 18, through wheel 84 andinto channel 52 for assembly, as described herein. Wheel 84 isconfigured to actuate rotation of inner shaft 56 and screw 64, asdescribed herein. Wheel 84 includes a surface 86 that defines a cavity88. Cavity 88 is configured for disposal of a correspondingly shapedportion of inner shaft 56, as shown in FIGS. 9 and 9A.

Inner shaft 56 extends between an end 60 and an end 62. End 60 isengageable with wheel 84 for rotation of inner shaft 56 and screw 64, asdescribed herein. Surface 86 engages end 60 in an interference fit tofacilitate simultaneous rotation of wheel 84 and inner shaft 56. In someembodiments, surface 86 defines a double-D cross section for a matingengagement with correspondingly shaped end 60 of inner shaft 56. In someembodiments, cavity 88 includes various configurations, such as, forexample, hexalobe, cruciform, phillips, square, hexagonal, polygonal,star cross sectional configuration for a mating engagement withcorrespondingly shaped portion of inner shaft 56. In some embodiments,wheel 84 includes a surface 90 configured to facilitate gripping ofwheel 84, such as, for example a knurled surface.

Screw 64 includes an inner surface 66. Surface 66 defines a cavity 68configured for disposal of a correspondingly shaped portion of end 62 ofinner shaft 56. Surface 66 engages inner shaft 56 in an interference fitto facilitate simultaneous rotation of inner shaft 56 and screw 64, asdescribed herein. In some embodiments, surface 66 defines a double-Dcross section for a mating engagement with correspondingly shaped end62. In some embodiments, cavity 68 includes various configurations, suchas, for example, hexalobe, cruciform, phillips, square, hexagonal,polygonal, star cross sectional configuration for a mating engagementwith a correspondingly shaped end 62. Screw 64 includes an outer surfacehaving a thread form 89. Thread form 89 is configured for engagementwith a mating surface, such as, for example, thread forms of arms 104,106 of bone fastener 100 to pull and or draw bone fastener 100 intoengagement with driver 12, as described herein.

Inner shaft 56 and screw 64 are configured for movement relative toouter sleeve 14. Screw 64 is inserted laterally into channel 52. Wheel84 is inserted laterally into cavity 82. With wheel 84 and screw 64provisionally assembled with outer sleeve 14, inner shaft 56 is insertedfrom end 18, through opening 94, through cavity 88 and into channel 52such that end 62 engages and passes through screw 64. Screw 64 isdisposed with inner shaft 56 and wheel 84 is disposed with collar body16, within channel 52, for assembly of the components of driver 12. Ashaft 70 is inserted and attached with end 18 to assemble and retaininner shaft 56, wheel 84, screw 64 within channel 52 in a relativelymovable configuration with outer sleeve 14, as described herein. In someembodiments, shaft 70 is attached with end 18 such that inner shaft 56,wheel 84, screw 64 freely slide, translate, rotate and/or float withinchannel 52. Inner shaft 56 retains screw 64 and wheel 84 with sleeve 14.In some embodiments, shaft 70 is welded with outer sleeve 14. In someembodiments, shaft 70 is configured to facilitate connection of driver12 with a surgical instrument, such as, for example, an actuator/drill250, as shown in FIG. 12. In some embodiments, shaft 70 includes quickconnect surfaces or keyed geometry, such as, for example, triangle, hex,square or hexalobe to facilitate connection with actuator 250.

End 20 of outer sleeve 14 includes a distal tip, such as, for example,drive 22, as shown in FIG. 4. Drive 22 is integrally connected ormonolithically formed with outer sleeve 14. This configurationfacilitates control of tolerances to optimize accuracy of the connectionof outer sleeve 14 with bone fastener 100. Drive 22 is engageable with aspinal implant, such as, for example, bone fastener 100. For example,drive 22 fits with and is engageable with a mating surface, such as, forexample, a socket 110 of bone fastener 100. Rotation of outer sleeve 14simultaneously rotates drive 22 to drive, torque, insert or otherwiseconnect bone fastener 100 with tissue, as described herein. In someembodiments, drive 22 includes a hexalobe geometry for a matingengagement with a correspondingly shaped socket 110. In someembodiments, drive 22 can alternatively include a cruciform, phillips,square, hexagonal, polygonal, star cross sectional configuration fordisposal of a correspondingly shaped socket 110.

Outer sleeve 14 includes an extension 30 and an extension 32. Extensions30, 32 include a wall 34 having a surface 36. Surface 36 is connectablewith an implant support, such as, for example, extender tab 152, asdescribed herein. Surface 36 defines a mating groove, such as, forexample, a pocket 38 configured for engagement with extender tab 152, asdescribed herein. Surface 36 is configured to resist and/or preventdisengagement of extender tab 152 from pocket 38, as described herein.

Extensions 30, 32 include a wall 40 having a surface 42. Surface 42 isconnectable with extender tab 152 a, as described herein. Surface 42defines a mating groove, such as, for example, a pocket 44 configuredfor engagement with extender tab 152 a, as described herein. Surface 42is configured to resist and/or prevent disengagement of extender tab 152a from pocket 44, as described herein.

Pockets 38, 44 are configured for engagement with extender tabs 152, 152a, as shown in FIGS. 5 and 8. Disposal of extender tabs 152, 152 a withpockets 38, 44 is configured to resist and/or prevent extender tabs 152,152 a from increasing diameter D1 when engaged with driver 12. In someembodiments, pockets 38, 44 are disposed parallel to axis a. In someembodiments, pockets 38, 44 are disposed at alternate orientationsrelative to axis a, such as, for example, at transverse, perpendicularand/or other angular orientations such as acute or obtuse, and/or may beoffset or staggered.

Bone fastener 100 includes receiver 102. Receiver 102 extends along axisa when connected with outer sleeve 14. Receiver 102 includes a pair ofspaced apart arms 104, 106 that define an implant cavity configured fordisposal of a component of a spinal construct, such as, for example, aspinal rod (not shown). Receiver 106 includes socket 110 configured forengagement with drive 22, as described herein. Receiver 108 includes aninner surface having a thread form located adjacent arm 104 and a threadform located adjacent arm 106. The thread forms of arms 104, 106 areconfigured for engagement with thread form 89 to retain bone fastener100 with driver 12, as described herein. Bone fastener 100 includes athreaded shaft 116. Shaft 116 is configured to penetrate tissue, suchas, for example, bone.

Arm 104 includes a break away tab 120 that is frangibly connected to arm104 such that manipulation of tab 120 relative to arm 104 can fractureand separate tab 120 from arm 104 at a predetermined force and/or torquelimit, as described herein. Arm 106 includes a break away tab 130 thatis frangibly connected to arm 106 such that manipulation of tab 130relative to arm 106 can fracture and separate tab 130 from arm 106 at apredetermined force and/or torque limit, as described herein. In someembodiments, as force and/or torque is applied to tabs 120, 130 andresistance increases, for example, the predetermined torque and forcelimit is approached.

In some embodiments, tabs 120, 130 can fracture and separate at apredetermined force or torque limit, which may be in a range ofapproximately 2 Newton meters (N-m) to 8 N-m. In some embodiments, tabs120, 130 and arms 104, 106 may have the same or alternate cross sectionconfigurations, may be fabricated from a homogenous material orheterogeneously fabricated from different materials, and/or alternatelyformed of a material having a greater degree, characteristic orattribute of plastic deformability, frangible property and/or break awayquality to facilitate fracture and separation of tabs 120, 130.

A bone fastener assembly 150 includes extender tabs 152, 152 a connectedwith bone fastener 100. Extender tabs 152, 152 a extend between aproximal end 172 and a distal end 174. Proximal end 172 includes springtips 176, 178, as shown in FIG. 8. Spring tips 176, 178 are aligned anddisposable with pockets 38, 44. Surfaces 36, 42 are configured to resistand/or prevent disengagement of spring tips 176, 178, as describedherein. Distal ends 174 are configured for slidable disposal of aportion of bone fastener 100, such as, for example, tabs 120, 130. Insome embodiments, tabs 120, 130 are configured to releasably fixextender tabs 152, 152 a with bone fastener 100 for connection withouter sleeve 14.

In use, bone fastener assembly 150 is connected with driver 12, asdescribed herein, and drive 22 is oriented for engagement with socket110. Drive 22 is engaged with socket 110 and screw 64 is disposed withinner shaft 56 and assembled with outer sleeve 14 for axial translationrelative to outer sleeve 14 and along inner shaft 56 between anon-locking configuration, as shown in FIG. 4, and a lockingconfiguration, as shown in FIG. 5, with a spinal implant, such as, forexample, bone fastener 100. In the non-locking configuration, screw 64is freely translatable relative to inner shaft 56 within an opening 51of channel 52, in the direction shown by arrows A in FIG. 4, androtatable relative to outer sleeve 14. This configuration allows drive22 to engage socket 110 prior to fixation of screw 64 with bone fastener100.

With bone fastener assembly 150 connected with outer sleeve 14, threadform 89 is aligned with the thread forms of arms 104, 106 for engagementtherebetween to retain bone fastener 100 with driver 12. Screw 64 iskeyed with the double D cross section of end 62 for simultaneousrotation with inner shaft 56 and wheel 84. Wheel 84 is manipulated forrotation such that inner shaft 56 rotates screw 64 relative to andindependent of outer sleeve 14. Thread form 89 engages the thread formsof arms 104, 106 and screw 64 axially translates into receiver 102 andrelative to inner shaft 56. The threaded engagement of screw 64 andreceiver 102 pulls and/or draws bone fastener 100 into the lockingconfiguration with driver 12 for releasable fixation therebetween. Drive22 is connected with outer sleeve 14, as described herein, and outersleeve 14 is rotated to drive, torque, insert or otherwise connect bonefastener 100 with adjacent tissue. Screw 64 remains releasably fixedwith receiver 102, independent of outer sleeve 14 rotation and/orengagement or friction with components of spinal implant system 10 asdescribed herein, to resist and/or prevent disengagement or unthreadingof screw 64 from receiver 102.

In some embodiments, driver 12 includes a navigation component 300, asshown in FIGS. 12 and 13. Driver 12 is configured for disposal adjacenta surgical site such that navigation component 300 is oriented relativeto a sensor array 302 to facilitate communication between navigationcomponent 300 and sensor array 302 during a surgical procedure, asdescribed herein. Navigation component 300 is configured to generate asignal representative of a position of bone fastener 100 relative todriver 12 and/or tissue. In some embodiments, the image guide mayinclude human readable visual indicia, human readable tactile indicia,human readable audible indicia, one or more components having markersfor identification under x-ray, fluoroscopy, CT or other imagingtechniques, at least one light emitting diode, a wireless component, awired component, a near field communication component and/or one or morecomponents that generate acoustic signals, magnetic signals,electromagnetic signals and/or radiologic signals. In some embodiments,navigation component 300 is connected with shaft 70 or outer sleeve 14via an integral connection, friction fit, pressure fit, interlockingengagement, mating engagement, dovetail connection, clips, barbs, tonguein groove, threaded, magnetic, key/keyslot and/or drill chuck.

Navigation component 300 includes an emitter array 304. Emitter array304 is configured for generating a signal to sensor array 302 of asurgical navigation system 306, as shown in FIG. 13 and describedherein. In some embodiments, the signal generated by emitter array 304represents a position of bone fastener 100 relative to driver 12 andrelative to tissue, such as, for example, bone. In some embodiments, thesignal generated by emitter array 304 represents a three dimensionalposition of bone fastener 100 relative to tissue.

In some embodiments, sensor array 302 receives signals from emitterarray 304 to provide a three-dimensional spatial position and/or atrajectory of bone fastener 100 relative to driver 12 and/or tissue.Emitter array 304 communicates with a processor of computer 308 ofnavigation system 306 to generate data for display of an image onmonitor 310, as described herein. In some embodiments, sensor array 302receives signals from emitter array 304 to provide a visualrepresentation of a position of bone fastener 100 relative to driver 12and/or tissue. See, for example, similar surgical navigation componentsand their use as described in U.S. Pat. Nos. 6,021,343, 6,725,080,6,796,988, the entire contents of each of these references beingincorporated by reference herein.

Surgical navigation system 306 is configured for acquiring anddisplaying medical imaging, such as, for example, x-ray imagesappropriate for a given surgical procedure. In some embodiments,pre-acquired images of a patient are collected. In some embodiments,surgical navigation system 306 can include an O-arm® imaging device 310sold by Medtronic Navigation, Inc. having a place of business inLouisville, Colo., USA. Imaging device 310 may have a generally annulargantry housing that encloses an image capturing portion 312.

In some embodiments, navigation system 306 comprises an image capturingportion 314 that may include an x-ray source or emission portion and anx-ray receiving or image receiving portion located generally or aspractically possible 180 degrees from each other and mounted on a rotor(not shown) relative to a track of image capturing portion 314. Imagecapturing portion 314 can be operable to rotate 360 degrees during imageacquisition. Image capturing portion 314 may rotate around a centralpoint or axis, allowing image data of the patient to be acquired frommultiple directions or in multiple planes. Surgical navigation system306 can include those disclosed in U.S. Pat. Nos. 8,842,893, 7,188,998;7,108,421; 7,106,825; 7,001,045; and 6,940,941; the entire contents ofeach of these references being incorporated by reference herein.

In some embodiments, surgical navigation system 306 can include C-armfluoroscopic imaging systems, which can generate three-dimensional viewsof a patient. The position of image capturing portion 314 can beprecisely known relative to any other portion of an imaging device ofnavigation system 306. In some embodiments, a precise knowledge of theposition of image capturing portion 314 can be used in conjunction witha tracking system 316 to determine the position of image capturingportion 314 and the image data relative to the patient.

Tracking system 316 can include various portions that are associated orincluded with surgical navigation system 306. In some embodiments,tracking system 316 can also include a plurality of types of trackingsystems, such as, for example, an optical tracking system that includesan optical localizer, such as, for example, sensor array 302 and/or anEM tracking system that can include an EM localizer. Various trackingdevices can be tracked with tracking system 316 and the information canbe used by surgical navigation system 306 to allow for a display of aposition of an item, such as, for example, a patient tracking device, animaging device tracking device 318, and an instrument tracking device,such as, for example, emitter array 304, to allow selected portions tobe tracked relative to one another with the appropriate tracking system.

In some embodiments, the EM tracking system can include theSTEALTHSTATION® AXIEM™ Navigation System, sold by Medtronic Navigation,Inc. having a place of business in Louisville; Colo. Exemplary trackingsystems are also disclosed in U.S. Pat. Nos. 8,057,407, 5,913,820,5,592,939, the entire contents of each of these references beingincorporated by reference herein.

Fluoroscopic images taken are transmitted a computer 314 where they maybe forwarded to computer 308. Image transfer may be performed over astandard video connection or a digital link including wired andwireless. Computer 308 provides the ability to display, via monitor 310,as well as save, digitally manipulate, or print a hard copy of thereceived images. In some embodiments, images may also be displayed tothe surgeon through a heads-up display.

In some embodiments, surgical navigation system 306 provides forreal-time tracking of the position of bone fastener 100 relative todriver 12 and/or tissue can be tracked. Sensor array 302 is located insuch a manner to provide a clear line of sight with emitter array 304,as described herein. In some embodiments, fiducial markers 330 ofemitter array 304 communicate with sensor array 302 via infraredtechnology. Sensor array 302 is coupled to computer 308, which may beprogrammed with software modules that analyze signals transmitted bysensor array 302 to determine the position of each object in a detectorspace.

Driver 12 is configured for use with an end effector 200 of a roboticarm R. End effector 200 includes a surface 202 that defines a cavity,such as, for example, a channel 204. Channel 204 is configured forpassage of bone fastener assembly 150 and disposal of driver 12. Roboticarm R includes position sensors (not shown), similar to those referencedherein, which measure, sample, capture and/or identify positional datapoints of end effector 200 in three dimensional space for aguide-wireless insertion of bone fasteners 100 with selected vertebrallevels. In some embodiments, the position sensors of robotic arm R areemployed in connection with surgical navigation system 306 to measure,sample, capture and/or identify positional data points of end effector200 in connection with surgical treatment, as described herein. Theposition sensors are mounted with robotic arm R and calibrated tomeasure positional data points of end effector 200 in three dimensionalspace, which are communicated to computer 308.

In assembly, operation and use, spinal implant system 10, similar to thesystems and methods described herein, is employed with a surgicalprocedure, such as, for example, a treatment of an applicable conditionor injury of an affected section of a spinal column and adjacent areaswithin a body. In some embodiments, one or all of the components ofspinal implant system 10 can be delivered or utilized as a pre-assembleddevice or can be assembled in situ. Spinal implant system 10 may becompletely or partially revised, removed or replaced.

In use, to treat vertebrae (not shown), a medical practitioner obtainsaccess to a surgical site in any appropriate manner, such as throughincision and retraction of tissues. In some embodiments, spinal implantsystem 10 can be used in any existing surgical method or techniqueincluding open surgery, mini-open surgery, minimally invasive surgeryand percutaneous surgical implantation, whereby the vertebrae isaccessed through a mini-incision, or sleeve that provides a protectedpassageway to the area. Once access to the surgical site is obtained,the particular surgical procedure can be performed for treating thespine disorder.

An incision is made in the body of a patient and a cutting instrument(not shown) creates a surgical pathway for implantation of components ofspinal implant system 10. A preparation instrument (not shown) can beemployed to prepare tissue surfaces of the vertebrae as well as foraspiration and irrigation of a surgical region.

Pilot holes (not shown) are made in selected levels of vertebrae forreceiving bone fasteners 100. Bone fastener assembly 150 is connectedwith driver 12, as described herein. Drive 22 is engaged with socket 110and screw 64 is disposed in a non-locking configuration, as describedherein, such that screw 64 is freely translatable relative to innershaft 56 within an opening 51 of channel 52 and rotatable relative toouter sleeve 14. With bone fastener assembly 150 connected with outersleeve 14, wheel 84 is manipulated for rotation such that inner shaft 56rotates screw 64 relative to and independent of outer sleeve 14, asdescribed herein. Threaded engagement of screw 64 and receiver 102 pullsand/or draws bone fastener 100 into the locking configuration withdriver 12 for releasable fixation therebetween.

Driver 12, connected with bone fastener assembly 150, is oriented fordisposal with end effector 200 of robotic arm R, as described herein.The assembly of driver 12/bone fastener assembly 150 are disposed withchannel 204 for implantation of bone fasteners 100 with vertebraeemploying robotic arm R and/or surgical navigation system 306, asdescribed herein. Actuator 250 is connected with shaft 70 and drive 22engages bone fastener 100, as described herein, and outer sleeve 14 isrotated to drive, torque, insert or otherwise connect bone fastener 100with adjacent tissue. Screw 64 remains releasably fixed with receiver102, independent of outer sleeve 14 rotation and/or engagement orfriction with end effector 200 to resist and/or prevent disengagement orunthreading of screw 64 from receiver 102. In some embodiments, driver12 is manipulated to deliver one or more bone fasteners 100 to asurgical site including vertebrae. Sensor array 302 receives signalsfrom navigation component 300 to provide a three-dimensional spatialposition and/or a trajectory of the assembly of driver 12/bone fastenerassembly 150, which may be disposed with end effector 200, relative tovertebrae and/or components of spinal implant system 10 for display onmonitor 310.

Upon completion of a procedure, as described herein, the surgicalinstruments, assemblies and non-implanted components of spinal implantsystem 10 are removed and the incision(s) are closed. One or more of thecomponents of spinal implant system 10 can be made of radiolucentmaterials such as polymers. Radiomarkers may be included foridentification under x-ray, fluoroscopy, CT or other imaging techniques.In some embodiments, spinal implant system 10 may include one or aplurality of spinal rods, plates, connectors and/or bone fasteners foruse with a single vertebral level or a plurality of vertebral levels.

In some embodiments, one or more bone fasteners, as described herein,may be engaged with tissue in various orientations, such as, forexample, series, parallel, offset, staggered and/or alternate vertebrallevels. In some embodiments, the bone fasteners may comprise multi-axialscrews, sagittal adjusting screws, pedicle screws, mono-axial screws,uni-planar screws, facet screws, fixed screws, tissue penetratingscrews, conventional screws, expanding screws, wedges, anchors, buttons,clips, snaps, friction fittings, compressive fittings, expanding rivets,staples, nails, adhesives, posts, fixation plates and/or posts.

In one embodiment, spinal implant system 10 includes an agent, which maybe disposed, packed, coated or layered within, on or about thecomponents and/or surfaces of spinal implant system 10. In someembodiments, the agent may include bone growth promoting material, suchas, for example, bone graft to enhance fixation of the components and/orsurfaces of spinal implant system 10 with vertebrae. In someembodiments, the agent may include one or a plurality of therapeuticagents and/or pharmacological agents for release, including sustainedrelease, to treat, for example, pain, inflammation and degeneration.

In some embodiments, as shown in FIGS. 14 and 15, spinal implant system10, similar to the systems and methods described herein, includes adriver 412, similar to driver 12 described herein. Driver 412 isconfigured for connection with a multi-axial screw (MAS) 500. Driver 412can be employed with end effector 200 and/or surgical navigation system306, as described herein, for guide-wireless insertion of MAS 500 withtissue, similar to that described herein.

Driver 412 includes an outer sleeve 414. Outer sleeve 414 extendsbetween a proximal end 418 and a distal end 420. Outer sleeve 414includes a continuous and non-interrupted outer surface 450 that extendsbetween ends 418, 420. Surface 450 defines an interior channel 452.Channel 452 is configured for disposal of an inner shaft 456, similar toinner shaft 56, and a screw 464, similar to screw 64 described herein.Outer sleeve 414 includes a collar body 416, similar to collar body 16described herein, to facilitate disposal and access to a thumb wheel484, similar to wheel 84 described herein.

Inner shaft 456 is engageable with wheel 484 for rotation of inner shaft456 and screw 464, similar to that described herein. Screw 464 includesan outer surface having a thread form 489 configured for engagement withthread forms of arms 504, 506 of MAS 500 to pull and/or draw MAS 500into engagement with driver 412, as described herein. Inner shaft 456and screw 464 are configured for movement relative to outer sleeve 414.A shaft 470, similar to shaft 70 described herein, is inserted andattached with outer sleeve 414 to assemble and retain inner shaft 456,wheel 484, screw 464 within channel 452 in a relatively movableconfiguration with outer sleeve 414, similar to that described herein.

End 420 of outer sleeve 414 includes a distal tip, such as, for example,drive 422, similar to drive 22 described herein. Drive 422 is integrallyconnected or monolithically formed with outer sleeve 414 and fits withand is engageable with a mating surface, such as, for example, a socket(not shown) of MAS 500, similar to that described herein. Rotation ofouter sleeve 414 simultaneously rotates drive 422 to drive, torque,insert or otherwise connect MAS 500 with tissue, similar to thatdescribed herein.

In use, drive 422 is oriented for engagement with the socket of MAS 500.Drive 422 is engaged with the socket of MAS 500 and screw 464 isdisposed with inner shaft 456 and assembled with outer sleeve 414 foraxial translation relative to outer sleeve 414 and along inner shaft 456between a non-locking configuration and a locking configuration, withMAS 500, similar to that described herein. In the non-lockingconfiguration, screw 464 is freely translatable relative to inner shaft456 and rotatable relative to outer sleeve 414. With MAS 500 connectedwith outer sleeve 14, thread form 489 is aligned with the thread formsof arms 504, 506 to retain MAS 500 with driver 412. Wheel 484 ismanipulated for rotation such that inner shaft 456 rotates screw 464relative to and independent of outer sleeve 414. Thread form 489 engagesthe thread forms of arms 504, 506 and screw 464 axially translates intothe receiver of MAS 500 and relative to inner shaft 456. The threadedengagement of screw 464 and the receiver of MAS 500 pulls and/or drawsMAS 500 into the locking configuration with driver 412 for releasablefixation therebetween. Drive 422 is connected with outer sleeve 414, asdescribed herein, and outer sleeve 414 is rotated to drive, torque,insert or otherwise connect MAS 500 with adjacent tissue. Screw 464remains releasably fixed with the receiver of MAS 500, independent ofouter sleeve 414 rotation and/or engagement or friction with componentsof spinal implant system 10, as described herein, to resist and/orprevent disengagement or unthreading of screw 464 from the receiver ofMAS 500.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A surgical instrument comprising: a first memberincluding a drive engageable with a shaft of a bone fastener; a secondmember being rotatable relative to the first member and including ascrew connectable with a receiver of the bone fastener; an implantsupport including extender tabs configured for engagement with thereceiver; and a guide member including an inner surface defining acavity configured for disposal of a sleeve of the first member, theguide member including an image guide oriented relative to a sensor tocommunicate a signal representative of a position of the guide member,wherein the screw is axially translatable relative to an inner shaft ofthe second member between a non-locking configuration and a lockingconfiguration with a threaded surface of the bone fastener receiver. 2.A surgical instrument as recited in claim 1, wherein the drive isintegrally connected with the first member.
 3. A surgical instrument asrecited in claim 1, wherein the drive comprises a distal tip of thefirst member and is configured for disposal in a drive socket of theshaft.
 4. A surgical instrument as recited in claim 1, wherein the firstmember includes a wall surface connectable with the implant support. 5.A surgical instrument as recited in claim 4, wherein the wall surfaceincludes mating grooves that are engageable with the extender tabs.
 6. Asurgical instrument as recited in claim 4, wherein the wall surfacedefines a pocket surface engageable with proximal spring tips of theimplant support.
 7. A surgical instrument as recited in claim 1, whereinthe sleeve defines an inner cavity configured for disposal of the innershaft.
 8. A surgical instrument as recited in claim 7, wherein thesecond member includes a rotatable actuator connected with the innershaft.
 9. A surgical instrument as recited in claim 8, wherein therotatable actuator includes a knurled wheel including an inner surfaceengageable with the inner shaft for rotation therewith.
 10. A surgicalinstrument as recited in claim 7, wherein the engagement elementincludes an inner surface engageable with the inner shaft for rotationtherewith.
 11. A surgical instrument as recited in claim 1, wherein thescrew has an outer thread surface connectable with a mating surface ofthe receiver.
 12. A surgical instrument as recited in claim 1, whereinthe drive is integrally connected with a sleeve of the first member. 13.A spinal implant system comprising: a surgical instrument including anouter tubular sleeve extending between a proximal end and a distal endincluding a drive engageable with a bone fastener shaft, and an innershaft being rotatable relative to the sleeve and including a screwconnectable with a threaded surface of a bone fastener receiver; animplant support including extender tabs configured for engagement withthe bone fastener receiver; a guide member including an inner surfacethat defines a cavity configured for disposal of the sleeve and an imageguide being oriented relative to a sensor to communicate a signalrepresentative of a position of the guide member; and a tracking deviceincluding a sensor that receives the signal and communicates with aprocessor to generate data for display of an image from a monitor, theimage representing position of the guide member relative to tissue. 14.A spinal implant system as recited in claim 13, wherein the guide memberincludes an end effector of a robotic arm.
 15. A spinal implant systemas recited in claim 13, wherein the drive is integrally connected withthe sleeve.
 16. A spinal implant system as recited in claim 13, whereineach extender tab includes proximal spring tips engageable with a pocketsurface of the sleeve.
 17. A spinal implant system as recited in claim13, wherein the screw is axially translatable relative to the innershaft between a non-locking configuration and a locking configurationwith the threaded surface of the bone fastener receiver.
 18. A spinalimplant system comprising: a surgical instrument including an outertubular sleeve extending between a proximal end and a distal endincluding a drive engageable with a bone fastener shaft, and an innershaft being rotatable relative to the sleeve and including a screwconnectable with a threaded surface of a bone fastener receiver; animplant support including extender tabs configured for engagement withthe bone fastener receiver; and a guide member including an innersurface that defines a cavity configured for disposal of the sleeve andan image guide being oriented relative to a sensor to communicate asignal representative of a position of the guide member, wherein eachextender tab includes proximal spring tips engageable with a pocketsurface of the sleeve.
 19. A spinal implant system as recited in claim18, wherein the guide member includes an end effector of a robotic arm.